BLUE WAVE HAND SANITIZER- ethyl alcohol gel 
Adonis, LLC.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Blue Wave- Gel Hand Sanitizer

Active Ingredient(s)

Ethyl Alcohol 70% v/v. .......... Antimicrobial

Purpose

Antimicrobial, Hand Sanitizer

Use

Hand Sanitizer to help reduce bacteria on hands.

Warnings

For external use only. Flammable. Keep away from heat or flame

Do not use

When using this product avoid contact with eyes. If contact occurs, rinse rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation or redness devleops and lasts.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

Directions

Other information

Inactive ingredients

Glycerin, Deionized Water ,Aloe Barbadensis, Acrylates Copolymer ,Aminomethyl Propanol,Fragrance (Coconut)

Package Label - Principal Display Panel

bluewave

BLUE WAVE  HAND SANITIZER
ethyl alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77356-835
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) (UNII: JZ1374NL9E)  
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
GLYCERIN (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:77356-835-01236 mL in 1 BOTTLE; Type 0: Not a Combination Product05/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A05/01/2020
Labeler - Adonis, LLC. (116983147)

Revised: 6/2020
Document Id: a7492f91-174e-2ba5-e053-2995a90a8f47
Set id: 5f7b846f-57cc-4ea7-bf06-5f840c8d201d
Version: 1
Effective Time: 20200604
 
Adonis, LLC.